1Stability and storage
The design of the drug stability study was inadequate and/or not justified with a documented rationale.
Inspection Record
Groupe Dissan Inc. — Health Canada Inspection Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Laboratory and QC controls
The education, experience, and/or oversight of the individual in charge of the quality control department was inadequate.
3Other quality system
The recorded information or details were inadequate.
4Complaint and recall handling
The assessment, recording, follow-up, and/or investigation of complaints and/or other information about potentially defective products was inadequate.
5Laboratory and QC controls
The quality control department was not a distinct unit that functioned independently and reported to management independent of any other unit.
6Regulatory reporting and change control
The change control system was inadequate for ensuring changes are properly documented, evaluated, and/or approved.
7Laboratory and QC controls
The quality control department did not undertake all of the required activities.
8Equipment and facility
Evaluation of production processes, equipment, and/or materials was inadequate.
9Other quality system
The implementation of a self-inspection program was inadequate.
10Other quality system
The electronic system was not validated for its intended use.
11Computer system validation
The temperature and/or humidity control was inadequate. The evidence used to demonstrate the transportation and/or storage conditions of each lot or batch of the drug was inadequate. The guidelines and/or procedures were inadequate in ensuring storage and/or transportation conditions would maintain the quality and safe distribution of the drug. The calibration, inspection, and/or qualification of the equipment, including computerized systems, was inadequate.
12Complaint and recall handling
The written procedures for recalls were inadequate.
About this record
Extracted automatically from the document of the Health Canada inspection on 2025-09-26. The source is available at the link above.
This is a record of that moment. Inspection findings are usually followed by the company's response and corrective action, but this page does not know how that turned out. Do not read it as the current state; check the regulator's official announcements for the latest status.
Translation and classification are automated and may differ in nuance from the source.
